Clinical Trials Directory

Trials / Completed

CompletedNCT03229317

Respiratory Outcome of Children From the FEPED Cohort

Respiratory Outcome According to Early Maternal Vitamin D Status During Pregnancy in Children Aged 5 to 6 Years Old

Status
Completed
Phase
Study type
Observational
Enrollment
142 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
5 Years – 6 Years
Healthy volunteers
Not accepted

Summary

Early lung function deficits represent a significant risk factor for the evolution toward chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke exposure are already known to predispose children to develop a non-reversible obstructive ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less certain. In humans, low vitamin D concentrations during pregnancy are associated to an increased risk of asthma in children. In murine models, low vitamin D concentrations during pregnancy are associated to structural abnormalities of the airways in mouse pups. Investigators hypothesized that vitamin D play a role in early airways development, from the first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will study the association of airway resistance in children aged 5 to 6 years old with the concentration of vitamin D during the first trimester of pregnancy in their mothers.

Detailed description

Children aged 5 to 6 years old will be included from the FEPED cohort. The FEPED cohort is a cohort of French pregnant women designed to study the association between vitamin D status during pregnancy and the risk of pre-eclampsia. Vitamin D concentration at first and third trimester of pregnancy as well as in cord blood is available for 1400 women. Investigators will include 200 children born from these women. Children will undergo lung function tests and prick-tests and parents will answer the ISAAC questionnaire that is a standardised questionnaire designed to evaluate asthma and rhinitis symptoms. The main outcome of this study will be specific airway resistance. The investigators will look for an association between specific airway resistance and vitamin D concentration measured during the first trimester of pregnancy in their mothers.

Conditions

Interventions

TypeNameDescription
OTHERPlethysmographyLung plethysmography

Timeline

Start date
2018-01-31
Primary completion
2020-12-16
Completion
2020-12-16
First posted
2017-07-25
Last updated
2026-01-15

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03229317. Inclusion in this directory is not an endorsement.